Small Science Popularization of Existing Chemical Substances Registration in Taiwan

Release time:

2020-10-28 11:52

According to statistics, up to now, the number of existing chemical substances in Taiwan has reached 101,089, which is a huge number. Therefore, most of the chemical substances sold to Taiwan are existing chemical substances. This article will combine the relevant laws and regulations in Taiwan to popularize the existing chemical substance registration in Taiwan, including the laws and regulations, registration types, data requirements, countermeasures, etc., hoping to help everyone cope with the existing chemical substance registration in Taiwan.

Regulatory situation

New chemical substances and existing chemical substances in Taiwan are regulated by the "Measures for the Registration of Information on New Chemical Substances and Existing Chemical Substances" under the "Measures for the Administration of Toxic Chemical Substances" (TCSCA, referred to as the Toxic Control Law). It was officially implemented on December 11, 2014, and the centralized management department is Taiwan's "Environmental Protection Agency" (EPA).

The Drug Administration Law requires that before existing chemical substances are produced and imported in Taiwan, they must apply to the "Environmental Protection Agency" in Taiwan for registration, and production and import activities can only be carried out after approval.

Definition of existing substances

The list of chemical substances in Taiwan is referred to as TCSI, which is the basis for judging new chemical substances and existing chemical substances. The list of TCSI is the existing chemical substances in Taiwan. The website of the list is as follows:http://csnn.osha.gov.tw/content/home/Substance_Home.aspx

Registration Type

The types of registration of existing chemical substances in Taiwan include the first phase of registration and standard registration, in which the first phase of registration is divided into pre-registration and post-pre-registration.

Starting from April 1, 2016, if the annual tonnage of production or import exceeds 0.1t for the first time in Taiwan, post-landing is required. Officials collected data on chemical substances active in Taiwan from the first phase of the registration, which selected high-hazard, high-exposure or serious lack of data to carry out standard registration in stages.

Registrant

According to the relevant provisions of the Drug Administration Law, manufacturers and importers in Taiwan can register existing chemical substances in Taiwan, while enterprises in non-Taiwan regions cannot directly register, and must be registered by their importers or agents (TPR) appointed by importers in Taiwan. Local importers or TPR provide necessary information support or relevant information.

In addition, enterprises in Taiwan can also entrust TPR to register.

Countermeasures

Time	Countermeasures
From 1 April 2016	Phase I registration of existing chemical substances (post-pre-registration)
January 1, 2020-December 31, 2021	The first batch of 106 existing chemical substance standard registration (>100t/a)
January 1, 2020-December 31, 2022	The first batch of 106 existing chemical substance standard registration (1-100t/a)
From January 1, 2020	Submission of annual reports on approved existing chemical substances

Information Requirements

Through the above introduction, we have learned that there are two types of post-registration pre-registration and standard registration of existing chemical substances. What are their respective data requirements?

Post Pre-Registration

The material requirements for pre-registration of existing chemical substances in Taiwan are relatively simple, and do not require physical, chemical, toxicological, ecological and other data, and only need to provide the following basic information:

Ø Basic information of the registrant

Ø Basic material identification data

Ø Production or import of substances

Production or use information

Standard Registration

The existing chemical substance standard registration in Taiwan is divided into four levels. The higher the level, the more information required. The details are as follows:

Major data items	First level	Second level	Third level	Fourth level
1. Basic identification information of registrant and substance	★	★	★	★
2. Material manufacture, use and exposure information	★	★	★	★
3. Hazard classification and labeling	★	★	★	★
4. Safe use of information	★	★	★	★
5. Physical and chemical characteristics data items	★	★	★	★
6. Toxicological Information Project	★	★	★	★
7. Ecotoxicological Information Project	★	★	★	★
8. Hazard Assessment Information		★	★	★
9. Exposure Assessment Information		★	★	★

Description:

1. If the existing chemical substances meet the category 1 hazard classification of carcinogenic, germ cell mutagenic or reproductive toxic substances (CMR), they shall submit higher registration data items according to their annual production or import tonnage;

2. According to the different registration levels, the specific data to be submitted for the three major data items 5, 6 and 7 are different. Some of the toxicological and ecotoxicological data can be submitted to the test plan first instead of the test report.

Joint registration

If different registrants jointly or successively apply for the registration of the same existing chemical substance, each registrant may agree to apply for the joint use of the information required for registration. Registrants may choose to register individually or jointly.

Enterprises interested in participating in joint registration can enter the existing joint registration communication platform for chemical substance standard registration and apply to join the substance communication group, then they can contact other joint registrants and agree on joint registration matters.

New Anrun advisory tips:

For late pre-registration substances, because the process is relatively simple, the required information is relatively simple, the cost is relatively low, and the cycle is relatively short, it is recommended that enterprises selling late pre-registration substances to Taiwan can carry out late pre-registration as soon as possible so as not to affect trade.

For standard registration substances above 100t/a, the buffer period is only 2 years (January 1, 2020-December 31, 2021), while the standard registration period is about 7-11 months (including the total period of one correction or two correction times). Now it is approaching the end of 2020, and the time is really tight. It is suggested that enterprises start to make preparations as soon as possible, such as collecting data and looking for TPR, so as not to miss the deadline and affect trade.

Attached: List of the first batch of existing chemical substance standard registration

Serial Number	CAS No.	Chinese name	English Name
1	1333-86-4	Carbon black	Carbon black
2	108-88-3	Toluene	Toluene
3	128-37-0	2,6-di-tert-butyl-p-methylphenol	2,6-Ditert-butyl-4-methyl phenol
4	107-21-1	1,2-Ethylene glycol	Glycol
5	111-76-2	2-Butoxyethanol	2-Butoxyethanol
6	1314-13-2	Zinc Oxide	Zinc oxide
7	25068-38-6	4,4 '-(1-Methylethylene) biphenol, polymer with (chloromethyl) oxirane	Phenol, 4,4'- (1-methylethylidene)bis-, polymer with (chloromethyl)oxirane
8	872-50-4	1-methyl -2-pyrrolidone	2-Pyrrolidinone, 1-methyl-
9	141-43-5	2-amino ethanol	2-Aminoethanol
10	111-46-6	diethylene glycol	Diglycol
11	108-95-2	Phenol	Phenol
12	1336-21-6	Ammonium hydroxide	Ammonium hydroxide
13	108-94-1	Cyclohexanol Phosphate	Phytic acid
14	101-68-8	Diphenylmethane-4, 4 '-diisocyanate	Diphenyl methane-4,4'-diisocyanate
15	7664-93-9	sulfuric acid	Sulfuric acid
16	1309-64-4	Antimony trioxide	Antimony oxide
17	100-42-5	Styrene	Styrene
18	95-63-6	1,2,4-Trimethylbenzene	Unsym-trimethylbenzene
19	79-10-7	Acrylic	Propenoic acid
20	110-54-3	n-Hexane	n-Hexane
21	556-67-2	octamethylcyclotetrasiloxane	Cyclotetrasiloxane, octamethyl-
22	91-20-3	Naphthalene	Naphthalene
23	105-60-2	Caprolactam	Caprolactam
24	108-67-8	1,3,5-Trimethylbenzene	Sym-Trimethylbenzene
25	115-86-6	triphenyl phosphate	Triphenyl phosphate
26	7722-84-1	Hydrogen peroxide	Hydrogen peroxide
27	127-19-5	N ,N-Dimethylacetamide	N,N-Dimethylacetamide
28	107-15-3	1,2-Diaminoethane	1,2-Diaminoethane
29	9016-87-9	Polymethylene polyphenylene isocyanate	Isocyanic acid, polymethylenepolyphenylene ester
30	7664-41-7	Ammonia	Ammonia
31	142-82-5	Heptane	Heptane
32	80-43-3	dicumyl peroxide	Dicumyl peroxide
33	149-57-5	2-ethylhexanoic acid	2-Ethyl hexoic acid
34	71-23-8	n-propanol	n-Propanol
35	79-41-4	α-Methacrylic Acid	Α-Methylacrylic acid
36	101-02-0	triphenyl phosphite	Triphenyl phosphite
37	100-97-0	Urotropine	Urotropine
38	75-59-2	tetramethylammonium hydroxide	Tetramethyl ammonium hydroxide
39	409-21-2	Silicon Carbide	Silicon carbide
40	26523-78-4	Tris (nonylphenol) phosphite	Phenol, nonyl-, phosphite (3:1)
41	10043-01-3	aluminum sulfate	Aluminium sulfate
42	144-62-7	Oxalic acid	Oxalic acid

43	4098-71-9	1,3, 3-Trimethyl-5-isocyanato-1-isocyanato acid (base) methylcyclohexane	Cyclohexane, 5-isocyanato-1- (Isocyanatomethyl)-1,3,3-trimethyl-
44	140-88-5	ethyl acrylate	Ethyl acrylate
45	108-87-2	Methyl cyclohexane	Methylcyclohexane
46	119-61-9	Benzophenone	Diphenyl ketone
47	25973-55-1	2-[2-Hydroxy-3, 5-bis (1,1-dimethylpropylphenyl)]-2H-benzotriazole	Phenol, 2-(2H-benzotriazol-2-yl)-4,6-bis(1,1- dimethylpropyl)-
48	123-77-3	diazenediamide	Diazenedicarboxamide
49	7631-90-5	Sodium bisulfite	Solfurous acid, monosodium salt
50	111-77-3	diethylene glycol monomethyl ether	Diethylene glycol monomethyl ethere
51	107-22-2	Glyoxal	Glyoxal
52	103-23-1	di (2-ethylhexyl) adipate	By (2-Ethylhexyl) adipate
53	1303-86-2	boron trioxide	Boron oxide
54	42978-66-5	2-(1-methyl -1, 2-ethylidene) bis (β-methoxyethyl) acrylate	2-Propenoic acid, (1-methyl-1,2-ethhanedyl)bis[oxy(methyl-2,1-ethanediyl)] ester
55	1313-99-1	Nickel oxide	Nickel oxide
56	793-24-8	N-(1-(S)-ethoxycarbonyl-3-phenylpropene base)-L-alanyl-N-carboxylic anhydride	N-(1-(S)-Ethoxycarbonyl-3-phenylpropyl)-L- alanyl-N-carboxyanhydride
57	2687-91-4	2-(5-Ethyl-2-pyridine) ethanol	2-(5-Ethyl-2-pyridyl)ethanol
58	5873-54-1	1-isocyanato-2-[(4-isocyanatophenyl) methyl] benzene	Benzene, 1-isocyanato-2-[(4- isocyanatophenyl)methyl]-
59	111-15-9	2-ethoxyethyl acetate	Ethanol, 2-ethoxy-, acetate
60	98-83-9	2-benzene propylene	2-Phenylpropene
61	106-91-2	2-methyl -2-acrylic acid oxiranylmethyl Ester	2-Propenoic acid, 2-methyl-, oxiranylmethyl ester
62	75-56-9	2,2-Bis [[(isodecyloxy) oxy] methyl]- 1,3-Propanediyl diisodecanoate	Isodecanoic acid, 2,2-bis[[(1-oxoisodecyl)oxy]methyl]-1,3- propanediyl ester
63	98-54-4	p-tert-butylphenol	4-tert -Butyl phenol
64	7757-79-1	Potassium nitrate	Nitric acid, potassium salt
65	7646-85-7	Zinc chloride	Zinc chloride
66	100-52-7	Benzaldehyde	Benzaldehyde
67	552-30-7	1,3-Dihydro-1,3-dioxo-5-isobenzofuran pyranyl carboxylic acid	5-Isobenzofurancarboxylic acid, 1,3-dihydro- 1,3-dioxo-
68	57693-14-8	C. I. Acid Black 172	Chromate(3-),bis [3-hydroxy-4-[2-hydroxy-1- naphthalenyl) ]-7-nitro-1- naphthalenesulfonato(3-)]-, trisodium
69	79-94-7	[3-Hydroxy-4-[(2-Hydroxy-1-Naphthyl) Couple N]-7-Nitro -1-Naphthalene Sulfonate (3-)][1- [(2-Hydroxy 4-Nitrophenyl) Azo] 2-Naphthol (2-)]-Chromic Acid (2-) Sodium Hydrogen	Chromate(2-),[3-hydroxy-4-[(2-hydroxy-1- naphthalenyl) 6-nitro-1- naphthalenesulfonato(3-)][1-[(2-hydroxy-4-nitrophenyl) 2-naphthalenolato(2-)]-, sodium hydrogens
70	75-91-2	tert-butyl hydroperoxide	Tert-butyl hydroperoxide
71	95-33-0	cis 5-(3-hexenyl) dihydro -2(3H)-furane pyrone	2(3H)-Furanone, 5-(3-hexenyl)dihydro-,(Z)-
72	10035-10-6	hydrobromic acid	Hydrobromic acid

73	2451-62-9	1,3, 5-Tris (oxiranylmethyl)-1,3, 5-triazine-2, 4,6(1H,3H,5H)-trione	1,3,5-Triazine-2,4,6(1H,3H,5H)-trion, 1,3,5- Tris(oxiranylmethyl)-
74	7550-45-0	Titanium tetrachloride	Titanium chloride (T-4)-
75	80-15-9	2,4-Dimethylcyclohexylmethanol	Cyclohexanemethanol, 2,4-dimethyl-
76	597-82-0	(O ,O ,O-triphenyl) thiophosphoric acid ester	Phosphorothioic acid,O,O,O-triphenyl ester
77	111-65-9	3-Octanone	3-Octanone
78	7681-49-4	Sodium fluoride	Sodium fluoride
79	7786-81-4	Nickel sulfate	Sulfuric acid, nickel(2 ) salt (1:1)
80	100-21-0	phthalic acid	p-Phthalic acid
81	13770-89-3	nickel sulfamate	Nickel sulfamate
82	96-76-4	2,4-Di-tert-butylphenol	2,4-Ditertbutylphenol
83	95-48-7	triethyl methyl silicate	Silicic acid, triethyl methyl ester
84	10025-87-3	phosphorus oxychloride	Phosphoric trichloride
85	7758-19-2	Sodium chlorite	Chlorous acid, sodium salt
86	100-40-3	4-vinyl cyclohexene	Cyclohexene, 4-ethenyl-
87	90-43-7	o-phenyl phenol	o-Phenylphenol
88	101-80-4	4,4 '-Diaminodiphenyl Ether	4,4'-Diamino diphenyl ether
89	98-00-0	α-furfuryl alcohol	2-Furanmethanol
90	140-66-9	4-(1,1, 3,3-Tetramethylbutyl) phenol	P-(1,1,3,3-Tetromethylbutyl) phenol
91	4067-16-7	1,3,5,7-tetraaza tricyclo [3.3.1.L3.7] decyl alkane hydrochloride	1,3,5,7-Tetraazatricyclo[3.3.1.L3.7]decane, hydrochloride
92	78-79-5	2-Methyl 1,3-Butadiene	1,3-Butadiene, 2-methyl-
93	108-77-0	2,4, 6-trichloro-1, 3,5-triazine	2,4,6-Trichloro-1,3,5-triazine
94	108-91-8	Cyclohexylamine	Cyclohexanamine
95	7173-51-5	didecyl dimethyl ammonium chloride	1-Decanaminium,N-decyl-N,N-dimethyl-, chloride
96	7775-09-9	Sodium chlorate	Chloric acid, sodium salt
97	106-94-5	n-Propane bromide	n-Propyl bromide
98	15571-58-1	10-Ethyl-4, 4-dioctyl-7-oxo-8-oxa-3, 5-dithia-4-stannic acid 2-ethylhexyl ester	8-Oxa-3,5-dithia-4-stannatetradecanoic acid, 10-ethyl-4,4-dioctyl-7-oxo-, 2-ethylhexyl ester
99	6197-30-4	2-cyano -3,3-diphenyl -2-acrylic acid (2- ethyl hexyl) ester	2-Propenoic acid, 2-cyano-3,3-diphenyl-, 2- ethylhexyl ester
100	99-96-7	p-hydroxybenzoic acid	p-Hydroxybenzoic acid
101	8030-30-6	Naphtha	Naphtha
102	25013-16-5	(1,1-Dimethylethyl)-4-methoxyphenol	Phenol, (1,1-dimethylethyl)-4-methoxy-
103	110-00-9	Furan	Furan
104	64742-54-7	Hydrogenation of petroleum heavy alkane fraction	Distillates, oil, hydrotreated heavy paraffinic
105	64742-65-0	solvent dewaxing heavy paraffin fraction	Distillates, oil, solvent-dewax heavy paraffinic
106	64742-55-8	Hydrogenation of petroleum light alkane distillates	Oil, oil, hydrated wood, paraffinic